NDC 65862-419

Sulfamethoxazole and Trimethoprim 80 mg / 400 mg tablet

Where it's made

Mahabubnagar, India · makes it and tests it

No problems found Last FDA inspection Jan 18, 2023. 2 inspections on record.

Medchal, India · makes it and tests it

Problems found, fixed voluntarily Last FDA inspection Jul 21, 2023. 13 inspections on record, 1 with serious problems.

Mahabubnagar, India · makes it and tests it

Problems found, fixed voluntarily Last FDA inspection May 10, 2022. 7 inspections on record, 1 with serious problems.

Jul 7, 2021 · Class II · Terminated
Presence of Foreign Substance- Potential of metal contamination.
Lots: Batch SP1D19082AA3 & Batch SP1D19085AA3; Exp 08/2022
Aug 10, 2020 · Class II · Terminated
Presence of Foreign Substance: product complaints were received by the firm for the presence of metal wire in the tablet(s).
Lots: Lot #s: STSD19109-A, Exp. 05/31/2022; SP1D19083AA3, SP1D19084AA3, Exp. 08/31/2022.

Generic drug: Sulfamethoxazole and Trimethoprim: see every company that makes it
Form: tablet, oral
Strength: 80 mg / 400 mg
Approval: ANDA ANDA090624
On the market since: Feb 16, 2010
Package NDCs: 65862-419-01 65862-419-05 65862-419-20 65862-419-99
Official label: DailyMed (National Library of Medicine), updated Mar 12, 2025

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